Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239941 | 12523994 | 1 | I | 2015 | 20151222 | 20160704 | 20160704 | PER | US-JAZZ-2015-US-022327 | JAZZ | 27.29 | YR | M | Y | 68.27000 | KG | 20160704 | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125239941 | 12523994 | 1 | PS | XYREM | SODIUM OXYBATE | 1 | Oral | 2.25 G, BID | Y | U | 21196 | 2.25 | G | ORAL SOLUTION | |||||
| 125239941 | 12523994 | 2 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | DOSE ADJUSTMENTS | Y | U | 21196 | ORAL SOLUTION | |||||||
| 125239941 | 12523994 | 3 | SS | XYREM | SODIUM OXYBATE | 1 | Oral | 3.75 G, BID | Y | U | 21196 | 3.75 | G | ORAL SOLUTION | |||||
| 125239941 | 12523994 | 4 | SS | PROVIGIL | MODAFINIL | 1 | UNK | Y | 0 | TABLET | |||||||||
| 125239941 | 12523994 | 5 | C | EXCEDRIN EXTRA STRENGTH | ACETAMINOPHENASPIRINCAFFEINE | 1 | UNK | U | 0 | ||||||||||
| 125239941 | 12523994 | 6 | C | Omega 3 fish oil | FISH OILOMEGA-3 FATTY ACIDS | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125239941 | 12523994 | 1 | Insomnia |
| 125239941 | 12523994 | 4 | Product used for unknown indication |
| 125239941 | 12523994 | 5 | Product used for unknown indication |
| 125239941 | 12523994 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125239941 | 12523994 | Anxiety | |
| 125239941 | 12523994 | Dyskinesia | |
| 125239941 | 12523994 | Muscle spasms | |
| 125239941 | 12523994 | Muscle tightness | |
| 125239941 | 12523994 | Restlessness | |
| 125239941 | 12523994 | Tension | |
| 125239941 | 12523994 | Tremor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125239941 | 12523994 | 1 | 201511 | 201511 | 0 | |
| 125239941 | 12523994 | 2 | 2015 | 2015 | 0 | |
| 125239941 | 12523994 | 3 | 201512 | 0 | ||
| 125239941 | 12523994 | 4 | 20150701 | 20151211 | 0 | |
| 125239941 | 12523994 | 5 | 20151119 | 0 | ||
| 125239941 | 12523994 | 6 | 20151119 | 0 |